Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07607639

Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis

This prospective observational case-control study aims to compare gingival crevicular fluid (GCF) biomarker profiles between children and young adults diagnosed with gingivitis. A total of approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded as they represent a transitional pubertal period characterized by significant hormonal fluctuations that may influence inflammatory responses and confound biomarker levels.

Clinical periodontal parameters including gingival index, plaque index, bleeding on probing, and probing depth will be recorded. In addition, GCF samples will be collected from a standardized tooth and analyzed for levels of IL-1β, TNF-α, IL-10, and MMP-8 using enzyme-linked immunosorbent assay (ELISA).

The primary objective of the study is to evaluate and compare inflammatory and anti-inflammatory cytokine profiles between the two age groups. The findings may contribute to understanding age-related differences in gingival inflammatory responses and the potential role of hormonal transition in periodontal disease expression during childhood and early adulthood.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

8 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Niğde Ömer Halisdemir University Faculty of Dentistry

Niğde, 51240, Turkey (Türkiye)

Location status: Recruiting

Location contact

Merdan Doğan

CONTACT

[email protected]

905422076565

About this study

Gingivitis is the most common reversible periodontal disease in children and young adults and is characterized by gingival inflammation without periodontal attachment loss. Gingival crevicular fluid (GCF) contains inflammatory mediators and biomarkers that reflect periodontal tissue response and disease activity.

This prospective observational case-control study aims to compare GCF biomarker profiles between children and young adults diagnosed with gingivitis. Approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded due to pubertal hormonal variability that may affect inflammatory biomarker levels.

Clinical periodontal parameters including Gingival Index, Plaque Index, Bleeding on Probing, and Probing Depth will be recorded. GCF samples will be collected from tooth #31 using standardized paper strips and analyzed for IL-1β, TNF-α, IL-10, and MMP-8 levels using ELISA.

The findings may contribute to understanding age-related differences in gingival inflammatory responses and biomarker expression in gingivitis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 8-12 years (child group) or 15-24 years (young adult group)
  • Clinical diagnosis of gingivitis
  • Presence of fully erupted tooth #31 with closed apex
  • Systemically healthy individuals
  • No history of periodontal treatment in the last 3 months
  • No antibiotic or anti-inflammatory drug use in the last 3 months
  • Good cooperation and willingness to participate
  • Written informed consent from participants or legal guardians (for minors)

Exclusion criteria

  • Age 13-14 years (transitional pubertal period)
  • Presence of periodontitis or other periodontal diseases
  • Systemic, genetic, or immunological diseases
  • Acute oral infections or conditions requiring emergency treatment
  • Orthodontic appliances in the sampling region
  • Smokers
  • Pregnant or lactating individuals
  • Individuals with cognitive, psychological, or physical disabilities affecting cooperation
  • Inadequate eruption or incomplete root development of tooth #31
  • Refusal to participate or withdrawal of consent

Treatment and study plan

Gingival Crevicular Fluid Biomarker Assessment

Diagnostic Test

Gingival crevicular fluid (GCF) samples will be collected from a standardized tooth (#31) using sterile absorbent paper strips (Periopaper®). Samples will be obtained after isolation and drying of the sampling site to avoid saliva contamination. Each strip will be placed gently in the gingival sulcus until mild resistance is felt and maintained for 30 seconds.

Collected samples will be immediately stored at -80°C until laboratory analysis. Levels of inflammatory and anti-inflammatory biomarkers including IL-1β, TNF-α, IL-10, and MMP-8 will be quantified using enzyme-linked immunosorbent assay (ELISA) kits according to manufacturer instructions.

This procedure is non-invasive and performed for diagnostic and comparative biomarker analysis purposes only.

Primary outcomes

  1. Gingival crevicular fluid TNF-α levels

    Time frame: Baseline

  2. Gingival crevicular fluid IL-1β levels

    Time frame: Baseline

  3. Gingival crevicular fluid IL-10 levels

    Time frame: Baseline

  4. Gingival crevicular fluid MMP-8 levels

    Time frame: Baseline

Secondary outcomes

  1. Gingival Index

    Time frame: Baseline

    Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Each surface will be scored between 0 and 3:

    0 = normal gingiva

    • = mild inflammation
    • = moderate inflammation with bleeding on probing
    • = severe inflammation with spontaneous bleeding Higher scores indicate worse gingival inflammation.

  2. Plaque Index

    Time frame: Baseline

    Dental plaque accumulation will be evaluated using the Silness and Löe Plaque Index. Each surface will be scored between 0 and 3:

    0 = no plaque

    • = plaque detectable by probe
    • = visible plaque accumulation
    • = abundant plaque accumulation Higher scores indicate poorer oral hygiene and greater plaque accumulation.

  3. Bleeding on Probing Scores Assessed by Periodontal Probing

    Time frame: Baseline

    Bleeding on probing will be evaluated using a periodontal probe after gentle probing of the gingival sulcus. Bleeding presence will be recorded dichotomously:

    0 = absence of bleeding

    1 = presence of bleeding Higher scores indicate greater gingival inflammation.

  4. Periodontal Probing Depth Measurements Assessed With Williams Periodontal Probe

    Time frame: Baseline

    Periodontal probing depth will be measured in millimeters using a Williams periodontal probe at six sites per tooth. Higher values indicate deeper periodontal pockets and worse periodontal condition.

Study contacts

Contact information is provided by the study sponsor or research team.

Aycan Dal Dönertaş

CONTACT

[email protected]

+903382252595

Selcen Özcan Bulut

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

Comparison of Gingival Crevicular Fluid Biomarkers Between Childhood Gingivitis and Adolescent Gingivitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 26, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.